Chapter
7 on “Contract Manufacture and Analysis” (which has become “Outsources
Activities”).

The
revised Chapters 1, 2, 6 & 7 of the PIC/S GMP Guide are based on the
equivalent Chapters of the EU GMP Guide with some minor differences in terms of
language.

Chapters
1, 2 & 7 have been aligned to ICH Q10 and the principles of “Pharmaceutical
Quality System” have been integrated. A section on consultants has been added
in Chapter 2. The scope of Chapter 7 has been expanded beyond the scope of
“contract manufacture and analysis”. Both Chapters 1 and 7 have been renamed to
reflect the changes. In Chapter 6, all sections have been reviewed and amended
and a new section on “Technical transfer of testing methods” has been added.

The
revision has been successfully completed by the PIC/S Sub-Committee on the
Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB). The revised GMP
Guide (PE 009-13) will enter into force on 1st January 2017. All non-EEA
Participating Authorities of PIC/S (and Applicants) have been invited to
transpose the revised Chapters of the PIC/S GMP Guide into their own GMP
Guides.

1.GUIDE
TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS. See: PIC/S